510(k) · Cleared
Recalled · Class II · 2018Inspire 6 Hollow Fiber Oxygenator with Integrated Hardhell Reservoir, Inspire 6F Hollow Fiber Oxygenator with Integrated
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sorin Group Italia S.R.L. · DTZ Oxygenator, Cardiopulmonary Bypass
Cleared on Feb 12, 2013 as substantially equivalent to K113626 (Sorin Group Italia S.R.L., 2012) and 1 other predicate after a 14-day review. Its family tree reaches back 6 generations to 1992. It has been recalled once.
- Decided
- Feb 12, 2013
- Review
- 14 days
- Class
- Class II
- Product code
- DTZ
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 6 generations to K922933 (1992). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK922933 Sorin Monolyrh Integrated Membrane LungSorin Biomedica, Fiat, USA, Inc. · 1992
- 5 generations backK980600 D903 Avant Adult Hollow Fiber OxygenatorDideco S.P.A. · 1998
- 4 generations backK020351 D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber OxygenatorDideco S.P.A. · 2002
- 3 generations backK033323 D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2…Dideco S.P.A. · 2004 · Recalled
- 2 generations backK043323 D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell…Dideco S.R.L. · 2005 · Recalled
- 1 generation backK120185 Inspire 6F Hollow Fiber Oxygenator with Integrated Arterial Filter…Sorin Group Italia S.R.L. · 2012
- This deviceK130209 Inspire 6 Hollow Fiber Oxygenator with Integrated Hardhell…Sorin Group Italia S.R.L. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K922933 | Sorin Monolyrh Integrated Membrane Lung | Sorin Biomedica, Fiat, USA, Inc. | 1992 | — |
| −5 | K980600 | D903 Avant Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 1998 | — |
| −4 | K020351 | D 903 Avant 2 PH.I.S.I.O. Adult Hollow Fiber Oxygenator | Dideco S.P.A. | 2002 | — |
| −3 | K033323 | D 903 Avant Adult Hollow Fiber Oxygenator and D 903 Avant 2 PH.I.S.I.O. Adult… | Dideco S.P.A. | 2004 | 1 |
| −2 | K043323 | D 905 Eos Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy… | Dideco S.R.L. | 2005 | 1 |
| −1 | K120185 | Inspire 6F Hollow Fiber Oxygenator with Integrated Arterial Filter and… | Sorin Group Italia S.R.L. | 2012 | — |
| 0 (this device) | K130209 | Inspire 6 Hollow Fiber Oxygenator with Integrated Hardhell Reservoir, Inspire… | Sorin Group Italia S.R.L. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2001 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in DTZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new DTZ device
- #1 K240934 Quantum Perfusion Blood Oxygenator ECC…score 14.3 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K113626 | Inspire 6 Hollow Fiber Oxygenator with Integrated Hardshell Venous/Cardiotomy ReservoirSummary page 1…Blood Filter UNMODIFIED DEVICES: INSPIRE 6 hollow fiber oxygenator with integrated hardshell venous/cardiotomy reservoir (K1 13626) INSPIRE 6F hollow fiber oxygenator with integrated arterial f… | 2012 |
| * | K120185 | Inspire 6F Hollow Fiber Oxygenator with Integrated Arterial Filter and Hardshell…Summary page 1…E 6F hollow fiber oxygenator with integrated arterial filter and hardshell venous/cardiotomy reservoir (K120185) INSPIRE 6/6F with modified HVR Special 51 0(k) Sorin Group It… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 13, 2018 | Class II | Z-1918-2018 | Incorrect or no expiration date | Some integrated sterile INSPIRE family products contain an incorrect expiration date printed in the Unique Device Identification (UDI) bar code and readable code just beneath the barcode. Specifically, the expiration date is reported as… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 4 companies; a new generation was cleared every 3.5 years on median.
- 4 of the 14 ancestors have a recall of any class.
- 2 other devices also cite its predicate K113626.
How does its category compare?
All DTZ devicesDTZ Oxygenator, Cardiopulmonary Bypass: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · DTZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DTZ
124in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DTZ
1in 2025
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · DTZ
976in 2025
MAUDE reports naming product code DTZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 55 | 7 | 134 |
| 2008 | 3 | 88 | 5 | 105 |
| 2009 | 9 | 210 | 0 | 52 |
| 2010 | 2 | — | 1 | 119 |
| 2011 | 4 | 160 | 13 | 190 |
| 2012 | 9 | 90 | 14 | 215 |
| 2013 | 9 | 28 | 0 | 346 |
| 2014 | 5 | 28 | 2 | 764 |
| 2015 | 9 | 134 | 0 | 658 |
| 2016 | 3 | 62 | 1 | 443 |
| 2017 | 2 | — | 0 | 388 |
| 2018 | 3 | 72 | 2 (2) | 320 |
| 2019 | 5 | 90 | 1 | 489 |
| 2020 | 5 | 93 | 3 | 442 |
| 2021 | 5 | 336 | 1 (1) | 595 |
| 2022 | 2 | — | 6 | 559 |
| 2023 | 5 | 145 | 0 | 738 |
| 2024 | 3 | 124 | 0 | 535 |
| 2025 | 2 | — | 1 | 976 |
| 2026 | 3 | 137 | 0 | — |
What is it indicated for?
INSPIRE 6M: Hollow Fiber Oxygenator INSPIRE 6M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. INSPIRE 6M is intended to be used for 6 hours or less. INSPIRE HVR: Hardshell Venous/Cardiotomy Reservoir INSPIRE HVR is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects, defoams and…
Read the full statement (206 words)
INSPIRE 6M: Hollow Fiber Oxygenator
INSPIRE 6M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. INSPIRE 6M is intended to be used for 6 hours or less.
INSPIRE HVR: Hardshell Venous/Cardiotomy Reservoir
INSPIRE HVR is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects, defoams and filters venous blood and suction blood. INSPIRE HVR can be used post-operatively for chest drainage. INSPIRE HVR is intended to be used for 6 hours or less.
INSPIRE 6F M: Hollow Fiber Oxygenator
The INSPIRE 6F M is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It provides gas exchange support and blood temperature control. INSPIRE 6F M integrated arterial filter provides additional protection against air and solid emboli. INSPIRE 6F M is intended to be used for 6 hours or less.
INSPIRE HVR: Hardshell Venous/Cardiotomy Reservoir
INSPIRE HVR is intended for use in adult and small adult surgical procedures requiring cardiopulmonary bypass. It collects, defoams and filters venous blood and suction blood. INSPIRE HVR can be used post-operatively for chest drainage. INSPIRE HVR is intended to be used for 6 hours or less.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130209 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130209: Inspire 6 Hollow Fiber Oxygenator with Integrated Hardhell Reservoir, Inspire 6F Hollow Fiber Oxygenator with Integrated.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130209
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026